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Bedside Ultrasound in the Diagnosis of Ankle Fractures in Children

Primary Purpose

Ankle Fracture

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ankle Fracture

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 2-18 years old
  • ankle ray ordered in ER

Exclusion Criteria:

  • open fracture
  • multi-system trauma/other significant injuries
  • history of ankle fractures? (Same ankle broken within past year)

Sites / Locations

  • Hasbro Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ultrasound for fracture

Arm Description

All patients receive ultrasound for potential ankle fracture.

Outcomes

Primary Outcome Measures

comparison of ultrasound to xray shows identical read
Ultrasound and the radiograph findings for each patient will be reviewed. The agreement between ultrasound and radiography will be expressed as a percentage of total number of studies performed.

Secondary Outcome Measures

Full Information

First Posted
April 11, 2011
Last Updated
December 3, 2012
Sponsor
Rhode Island Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01341015
Brief Title
Bedside Ultrasound in the Diagnosis of Ankle Fractures in Children
Official Title
Bedside Ultrasound in the Diagnosis of Ankle Fractures in Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhode Island Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Objectives: A lot of children who injure their ankles come to the emergency department for an evaluation, and often an X-ray of the ankle is obtained to determine if a bone fracture is present. In more than 85% of cases, however, the injury is a sprain and not a bone fracture and can be treated with rest, ice, elevation, and pain medications. X-rays obtained in the emergency departments are time consuming, often uncomfortable for the patient, and expose children to radiation, the long-term effects of which are not yet fully understand by doctors or scientists. Bedside ultrasound is a non-invasive and a non-painful device that does not produce radiation. It was been shown to determine the presence of bone fracture in childrens' wrists and forearms just as well as X-rays do. In our study, the investigators would like to determine if a bedside ultrasound can also be used to evaluate ankle fractures in children. Research Procedures: In our study, the investigators will ask the parents and children, who are scheduled to get an X-ray of their ankle in the emergency department, to examine their ankles with an ultrasound machine as well. Since the bedside ultrasound is not significantly time-consuming, does not require patients to remain still, and is readily available in the department, the procedure will be performed while kids are waiting to get an X-ray, getting registered, or awaiting further treatment. On the data collection form, the investigators will document the patients' names, birthdates, medical record numbers so that their X-ray results can be compared to the ultrasound results for the purpose of the study. The information will be stored in a secure cabinet in a locked office. The investigators will also document which side is injured, where the patient feels pain and what the ankle looks like to help perform the ultrasound. The results of both the ultrasound and X-ray will be documented for each patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fracture

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ultrasound for fracture
Arm Type
Experimental
Arm Description
All patients receive ultrasound for potential ankle fracture.
Intervention Type
Other
Intervention Name(s)
Ultrasound
Other Intervention Name(s)
ultrasound for fractures
Intervention Description
Single interventional group - patients agree to an ultrasound of potential ankle fracture, to be compared to standard of care xray.
Primary Outcome Measure Information:
Title
comparison of ultrasound to xray shows identical read
Description
Ultrasound and the radiograph findings for each patient will be reviewed. The agreement between ultrasound and radiography will be expressed as a percentage of total number of studies performed.
Time Frame
At ER visit (day 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 2-18 years old ankle ray ordered in ER Exclusion Criteria: open fracture multi-system trauma/other significant injuries history of ankle fractures? (Same ankle broken within past year)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Otto Liebmann, MD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hasbro Children's Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Bedside Ultrasound in the Diagnosis of Ankle Fractures in Children

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